Nouvelle déclaration d'incident
No de la demande: 2017-6929
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0058583 (Report 444800)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: NORTH CAROLINA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
German Boxer
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in approximately Jul-2017, the dog died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss product use on another pet in the home and not to report the death in this event
Mort
N-Unlikely: Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover owner does not believe in product connection as the reason for the initial phone call was to discuss product use on another pet in the home and not to report the death in this event. Even though low level of information is provided (as unknown time to onset), considering the known product profile, sufficient information exists to conclude that the product did not cause the event and product involvement remains unlikely. The reason for the initial phone call was to discuss product use on another pet in the home and not to report the death in this event.